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- The most promising Covid vaccine candidates are Pfizer and BioNtech; Modern; AstraZeneca and the University of Oxford; and Janssen-Johnson & Johnson
- While three of the companies’ PHASE 3 trials have released preliminary results, one is still ongoing.
- We take a look at what we know about the status of vaccines today, as well as manufacturing agreements between companies and specific countries.
Pfizer and BioNtech, Moderna, AstraZeneca and the University of Oxford, and Johnson & Johnson are the most promising Covid-19 vaccine candidates that have broken all speed records in the history of vaccine development.
It has been just over two weeks since Moderna’s Covid-19 vaccine trial results were shown to be 94.5% effective (the chance that a vaccine will work in people), and since the announcement of the end of the Pfizer and BioNtech trial, which also revealed an impressive 95% efficiency.
The results of the Oxford University trial and AstraZeneca were also promising, with up to 90% efficacy reported, although there has been some confusion.
Full test data from all companies has yet to be published, but will soon be published in peer-reviewed medical journals for public scrutiny.
We take a look at where some of the most prominent vaccines are at the moment, including the status of the Johnson & Johnson trial (vaccine being developed by Janssen).
Modern vaccine
The Drugmaker Moderna vaccine trial involved 30,000 volunteers and included high-risk groups, such as the elderly. In this study, 15,000 volunteers received the actual vaccine, while the rest received placebo injections. No serious side effects were reported in those who received injections of the royal vaccine.
On Monday, the biotech company announced its final results and stated that they are applying for an emergency use authorization in the US and Europe for their mRNA vaccine, called mRNA-1273, so that it can be recommended for widespread use.
This means that regulators will now evaluate the vaccine’s test data and conclude if it is safe and effective enough to recommend its implementation.
Pfizer and BioNtech vaccine
Pfizer and the German company BioNtech, whose vaccine (BNT162b2) also incorporates mRNA technology and included a large-scale phase 3 trial of more than 43,000 volunteers, applied for the same approval in the United States.
On Wednesday, the UK’s independent regulator, the Medicines and Healthcare Products Regulatory Agency (MHPRA), granted approval for emergency use. According to the Wall street journal, distribution of the vaccine is expected to occur in limited quantities within a few days.
Under normal conditions, vaccines would require authorization from the European Medicines Agency (EMA) until the end of the Brexit transition on December 31. However, the British government last week granted the MHPRA to prevent this and temporarily authorize the products, in cases of urgent public need, it explains. Bloomberg.
AstraZeneca Vaccine and Oxford University
The AstraZeneca and Oxford University study revealed promising results from their trials in the US and Brazil last week and, like the Moderna and Pfizer vaccines, UK regulators are also reviewing data on this vaccine, called AZD1222, for emergency approval.
However, a growing number of concerns have arisen since their announcement regarding efficacy levels, as they reported three levels: One dosing regimen produced 62% efficacy, while the other reached 90%, leading to at an average of 70%, significantly lower than the levels. reported by the other two top leading candidates.
While most of the volunteers in the trial received the correct dose for their two injections, some did not, by mistake, explains the BBC. Menelas Pangalos, an executive at AstraZeneca explained that the dosing error was made by a contractor, and that regulators were immediately notified once it was discovered, the The Times of New York City reports. Regulators then approved the plan to continue testing the vaccine at different doses.
The mistake had no consequences for the safety of the vaccine, and testing continues now so that more volunteers can be enrolled and immunized.
AstraZeneca is currently in discussions with the Food and Drug Administration (FDA) about including the half-dose regimen in its trials in the US, which currently have about 10,000 participants, an AstraZeneca spokesperson told CNN. Thursday.
Despite the concerns, the vaccine could be a game changer for the world than the other candidates, as it is much cheaper (about $ 3 to $ 4 per dose, compared to about $ 20 for the Pfizer vaccine and $ 32- $ 37 for Moderna’s vaccine), and has simpler storage and transportation requirements.
READ | Cold truth: South Africa will not be able to store these Covid vaccines. This is why.
In addition to this, AstraZeneca has pledged 300 million doses of its vaccine to COVAX, a partnership between GAVI, the vaccine alliance; the World Health Organization (WHO); and the Coalition for Epidemic Preparedness Innovations (CEPI) to ensure equitable distribution in 92 developing countries.
The Serum Institute of India (SII) and the Bill and Melinda Gates Foundation have also pledged to allocate up to 200 million doses of the AstraZeneca and / or Novavax candidate vaccines to low-income countries, a GAVI representative told CNN.
Moderna and Pfizer, on the other hand, have not promised any doses to COVAX, which may have to do with manufacturing capabilities.
The partnership would also guarantee access to the non-profit vaccine until at least July 2021 worldwide, and in perpetuity for low- and middle-income countries.
According to UK Prime Minister Boris Johnson, the vaccine could be ready for deployment in the “next few weeks”. The Guardian.
Johnson & Johnson vaccine
While all three companies have already reported encouraging initial results on their Covid vaccine candidates, the Ad26.SARS-CoV-2 vaccine, developed by the Belgian company Janssen, owned by Johnson & Johnson, is still being tested in its trials of stage 3.
According to a BBC report, the NIHR Center for Clinical Research in Southampton last month began recruiting 6,000 UK volunteers for a trial. Another 30,000 volunteers from other countries are expected to join phase 3 trials of the vaccine.
Half of the volunteers will receive two injections of the vaccine two months apart.
The large-scale trial already underway involves volunteers receiving one dose and is testing whether two doses result in stronger and longer-lasting immunity.
The BBC notes that it could take six to nine months before the results are released.
Who is in line to get the shots?
Moderna stated earlier this month that the launch of the vaccine for mRNA-1273 is planned for the US, with an expectation of 20 million doses for the country. They also mentioned that they plan to manufacture roughly 500 million to 1 billion doses globally in 2021.
On November 17, they announced a supply agreement with the UK government to supply mRNA-1273 in March 2021, subject to approval for use by UK regulatory authorities. The European Commission has also approved an agreement to secure 80 million doses of the vaccine.
According to a CNN report, Pfizer and BioNTech say they can manufacture up to 50 million doses in 2020 and 1.3 billion in 2021, while AstraZeneca says it expects a production capacity of up to three billion doses of the vaccine in 2021. keep going.
The UK government has already ordered 30 million injections of the Janssen-Johnson & Johnson vaccine.
Earlier last month, Health24 reported that South African pharmaceutical company Aspen signed an agreement with Johnson & Johnson to manufacture its candidate vaccine in Port Elizabeth.
Aspen SA group executive Stephen Saad told Health24 that if trials show positive results, manufacturing can begin in March 2021 and that the PE facility has the capacity to produce more than 300 million doses per year.
Although this does not necessarily place SA at an advantage to receive the vaccine, Johnson & Johnson is committed to having universal access to its vaccine (through the Bill & Melinda Gates Foundation) and to making up to 500 million doses available to users. low-income countries. at cost price.
